Hengrui's Airlui® (Adebrelimab) Becomes First China-Developed PD-L1 Inhibitor Approved for Perioperative NSCLC Treatment

Shanghai, China — Jiangsu Hengrui Pharmaceuticals Co., Ltd. has secured regulatory approval to expand the use of its homegrown cancer drug, marking a significant milestone in China's push to develop domestically produced immunotherapies for some of the most challenging forms of lung cancer.

The National Medical Products Administration approved Adebrelimab Injection — marketed under the brand name Airlui® — for use in combination with platinum-based chemotherapy as a neoadjuvant treatment, followed by Adebrelimab monotherapy as adjuvant treatment, in adult patients with resectable stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC) who have no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

The approval makes Airlui the first domestically developed PD-L1 inhibitor in China to gain approval for perioperative treatment of NSCLC, and represents the second indication for the drug in lung cancer. It was previously approved in February 2023 for first-line treatment of extensive-stage small cell lung cancer in combination with carboplatin and etoposide.

The regulatory green light came after Shanghai Shengdi Pharmaceutical Co., Ltd., a subsidiary of Hengrui, submitted data from a phase Ib/III randomized, double-blind, multicenter clinical trial known as SHR-1316-III-303. The study, led by Professor Wu Yilong of Guangdong Provincial People's Hospital, enrolled 501 patients with previously untreated, resectable stage II-IIIB NSCLC without EGFR mutations or ALK fusions.

Patients were randomized 1:1 to receive either three cycles of Adebrelimab (20 mg/kg) plus platinum-based chemotherapy as neoadjuvant therapy, followed by surgery and 16 cycles of Adebrelimab as adjuvant therapy, or placebo plus chemotherapy followed by surgery and placebo adjuvant treatment.

The interim analysis results were striking. The Adebrelimab-chemotherapy combination achieved a major pathological response (MPR) rate of 53.8%, nearly triple the 18.4% seen in the control group — a difference of 35.6 percentage points that proved statistically significant (p<0.0001). The pathological complete response (pCR) rate was 31.1% versus 7.6% in the control arm.

On the survival front, the two-year event-free survival (EFS) rate reached 74.8% in the treatment group compared with 55.5% in the control group, representing a 48% reduction in the risk of disease recurrence, progression, or death (hazard ratio = 0.52, one-sided p<0.0001). Overall survival also showed a clear benefit trend with an HR of 0.57.

The surgery rate was equally impressive at 88.8%, compared with 83.2% in the control group. According to a PubMed and MEDLINE database search conducted as of April 10, 2026, this represents the only perioperative lung cancer trial with a surgery rate exceeding 85%, and both the EFS rate and surgery rate are the highest reported in similar studies.

Subgroup analyses demonstrated consistent benefits across clinical stages, pathological subtypes, and PD-L1 expression levels, with the Adebrelimab-chemotherapy combination showing superior efficacy in both EFS and MPR endpoints. The overall safety profile was acceptable, with no new safety signals identified.

"The SHR-1316-303 study validates the significant clinical value of Adebrelimab in perioperative treatment of non-small cell lung cancer," said Professor Wu. "As the first domestically developed PD-L1 inhibitor approved for NSCLC perioperative treatment in China, Adebrelimab will provide a new treatment option. We look forward to this domestic innovation benefiting more lung cancer patients and steadily advancing the level of lung cancer diagnosis and treatment."

Feng Jie, President and Chief Operating Officer of Hengrui Pharma, called the approval "an important milestone in the innovative development of China's domestically developed anti-tumor drugs." She added: "It demonstrates our company's patient-centric philosophy. Looking ahead, Hengrui will continue to be driven by clinical needs, ensuring that China's innovative achievements benefit more patients globally."

The approval arrives at a critical juncture in China's fight against lung cancer. According to the latest report on China's cancer disease burden, lung cancer ranks first in both incidence and mortality among malignant tumors in the country. NSCLC accounts for approximately 80% to 85% of all lung cancer cases.

While radical surgical resection remains the primary treatment for early-stage NSCLC, post-operative recurrence continues to plague clinicians. A meta-analysis published in CHEST, encompassing 1,060 surgical study groups, revealed that even after successful tumor removal, more than half (50-66%) of stage II-III patients face the risk of recurrence within five years.

The addition of perioperative chemotherapy — whether neoadjuvant or adjuvant — to clinical practice has improved five-year survival rates by only about 5%, underscoring the urgent need for superior systemic treatment approaches. Recent breakthroughs in immunotherapy have offered new hope, with multiple phase III perioperative immunotherapy studies confirming that adding immunotherapy to neoadjuvant and adjuvant treatment stages can deliver significant survival benefits. These findings have become the new standard recommended by authoritative domestic and international guidelines.

Adebrelimab is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui. It works by specifically binding to the PD-L1 molecule, blocking the PD-1/PD-L1 pathway that leads to tumor immune tolerance, thereby reactivating the immune system's anti-tumor activity.

Hengrui is conducting multiple phase II-III clinical studies of Adebrelimab, exploring its therapeutic potential across a broad range of tumor types including non-small cell lung cancer, small cell lung cancer, cervical cancer, biliary tract cancer, gastric cancer, esophageal cancer, liver cancer, colorectal cancer, and renal cancer.

As an innovation-driven international pharmaceutical company, Hengrui has maintained R&D spending at more than 25% of revenue for multiple consecutive years. The company has secured approval for 25 Class 1 new drugs and 6 Class 2 new drugs in China, with over 100 self-developed products currently in clinical development and more than 400 clinical trials underway globally.

Hengrui's products have been commercialized in more than 50 countries. The company has completed 13 overseas business development deals for innovative drugs over the past three years, as it accelerates its global expansion through both independent development and strategic partnerships.